ID

19789

Description

NCT01117584 Astellas Phase 2b, Double-Blind, Randomized, Multicenter, Parallel Group, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy, Safety and Tolerability of a 12- Week Treatment with ASP1941 in Combination with Metformin in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone.

Keywords

Versions (2)
  1. 12/5/16 12/5/16 -
  2. 1/28/17 1/28/17 -
Uploaded on

January 28, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Visit 1 Run-In Genital infection History NCT01117584

English

Visit 1 Run-In Genital infection History NCT01117584

1 forms  
General Information
Description

General Information

Alias
UMLS CUI-1
C1508263
Diagnosis
Description

Diagnosis

Data type

text

Alias
UMLS CUI [1]
C0011900
Does the subject have a history of Genital Infection(s)?
Description

History of Genital Infections

Data type

boolean

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0019664
If yes, how many genital infections did the subject have in the past year?
Description

Number of Genital Infections

Data type

integer

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0237753
If one or more, please provide the details of the most recent historical infection.
Description

Details of most recent infection

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0332185
UMLS CUI [1,3]
C1522508
Site of infection
Description

Site of infection

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0475264
If Other, please specify
Description

Specification of other site of Infection

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0475264
Organism
Description

Organism

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0029235
Confirmed by Lab?
Description

Confirmation by lab

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0022877
UMLS CUI [1,3]
C0521091
Onset Date
Description

Onset Date

Data type

date

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0574845
Is Medical Condition ongoing?
Description

Ongoing Medical Condition

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0549178
Recovered Date
Description

Recovered Date

Data type

date

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C2004454
Was the infection symptomatic?
Description

Symptomatic Infection

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0231220
Was the infection treated?
Description

Treatment

Data type

text

Alias
UMLS CUI [1,1]
C0729552
UMLS CUI [1,2]
C0087111
LLT Code
Description

LLT Code

Data type

text

Alias
UMLS CUI [1]
C2347090
LLT Term
Description

LLT Term

Data type

text

Alias
UMLS CUI [1]
C2347090
PT Code
Description

PT Code

Data type

text

Alias
UMLS CUI [1]
C2347664
PT Term
Description

PT Term

Data type

text

Alias
UMLS CUI [1]
C2347664
HLT Code
Description

HLT Code

Data type

text

Alias
UMLS CUI [1]
C2348972
HLT Term
Description

HLT Term

Data type

text

Alias
UMLS CUI [1]
C2348972
HLGT Code
Description

HLGT Code

Data type

text

Alias
UMLS CUI [1]
C2347089
HLGT Term
Description

HLGT Term

Data type

text

Alias
UMLS CUI [1]
C2347089
SOC Code
Description

SOC Code

Data type

text

Alias
UMLS CUI [1]
C2347091
SOC Code
Description

SOC Term

Data type

text

Alias
UMLS CUI [1]
C2347091
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Similar models

Visit 1 Run-In Genital infection History NCT01117584

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
History of Genital Infections
Item
Does the subject have a history of Genital Infection(s)?
boolean
C0729552 (UMLS CUI [1,1])
C0019664 (UMLS CUI [1,2])
Number of Genital Infections
Item
If yes, how many genital infections did the subject have in the past year?
integer
C0729552 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Details of most recent infection
Item
If one or more, please provide the details of the most recent historical infection.
text
C0729552 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
Item
Site of infection
text
C0729552 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
Site of infection
Code List
Site of infection
CL Item
Vaginal (1)
CL Item
Labia (2)
CL Item
Uterus/Fallopian tubes/Ovaries (3)
CL Item
Urethra (4)
CL Item
Penis (5)
CL Item
Foreskin/Glands (6)
CL Item
Testicles/Epididymis (7)
CL Item
Other (8)
Specification of other site of Infection
Item
If Other, please specify
text
C0729552 (UMLS CUI [1,1])
C0475264 (UMLS CUI [1,2])
Item
Organism
text
C0729552 (UMLS CUI [1,1])
C0029235 (UMLS CUI [1,2])
Organism
Code List
Organism
CL Item
Bacterial (1)
CL Item
Viral (2)
CL Item
Fungal (3)
CL Item
Unknown (4)
Item
Confirmed by Lab?
text
C0729552 (UMLS CUI [1,1])
C0022877 (UMLS CUI [1,2])
C0521091 (UMLS CUI [1,3])
Confirmation by lab
Code List
Confirmed by Lab?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Onset Date
Item
Onset Date
date
C0729552 (UMLS CUI [1,1])
C0574845 (UMLS CUI [1,2])
Item
Is Medical Condition ongoing?
text
C0729552 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Ongoing Medical Condition
Code List
Is Medical Condition ongoing?
CL Item
No (1)
CL Item
Yes (2)
Recovered Date
Item
Recovered Date
date
C0729552 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
Item
Was the infection symptomatic?
text
C0729552 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Symptomatic Infection
Code List
Was the infection symptomatic?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Item
Was the infection treated?
text
C0729552 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Treatment
Code List
Was the infection treated?
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
LLT Code
Item
LLT Code
text
C2347090 (UMLS CUI [1])
LLT Term
Item
LLT Term
text
C2347090 (UMLS CUI [1])
PT Code
Item
PT Code
text
C2347664 (UMLS CUI [1])
PT Term
Item
PT Term
text
C2347664 (UMLS CUI [1])
HLT Code
Item
HLT Code
text
C2348972 (UMLS CUI [1])
HLT Term
Item
HLT Term
text
C2348972 (UMLS CUI [1])
HLGT Code
Item
HLGT Code
text
C2347089 (UMLS CUI [1])
HLGT Term
Item
HLGT Term
text
C2347089 (UMLS CUI [1])
SOC Code
Item
SOC Code
text
C2347091 (UMLS CUI [1])
SOC Term
Item
SOC Code
text
C2347091 (UMLS CUI [1])
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